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Pilot Study on Metabolic Effects of Fish Peptides and Vitamin D (BONITO)

Primary Purpose

Prediabetes, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Fish peptide supplement
Vitamin D supplement
Fish peptide + Vitamin D3 supplements
Placebo
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prediabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • overweight (BMI 25-40 kg/m2)
  • fasting triglycerides ≥ 1.5 mmol/L
  • fasting insulin ≥ 60 pmol/L
  • non-smoking
  • stable weight in the past 3 months

Exclusion Criteria:

  • diabetes
  • chronic diseases
  • taking drugs that could affect glucose or lipid metabolism
  • taking dietary supplements or natural health products
  • major surgery 3 months prior to the study
  • fish or seafood allergy
  • lactose intolerance

Sites / Locations

  • Institute of Nutrition and Functional Foods (INAF), Laval University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Fish peptide

Vitamin D

Fish peptide + Vitamin D

Control

Arm Description

Outcomes

Primary Outcome Measures

Serum glucose area under the curve (Glucose AUC)
The area under the curve for serum glucose concentration is calculated from 0-180min after 75g glucose is ingested

Secondary Outcome Measures

Serum insulin area under the curve (Insulin AUC)
Area under the curve for serum insulin
Serum C-peptide area under the curve (C-peptide AUC)
Area under the curve for serum C-peptide
Serum triglycerides concentrations
changes in the triglycerides concentration at each time point of the OGTT
Serum 25(OH)D concentrations
Changes in the 25(OH)D concentration measured before each OGTT
Cardiometabolic risk profile in serum
Changes in cardiometabolic profile measured in serum before each OGTT
Gene expression profile
peripheral blood mononuclear cells (PBMCs) gene expression

Full Information

First Posted
September 1, 2015
Last Updated
July 5, 2021
Sponsor
Laval University
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT02668159
Brief Title
Pilot Study on Metabolic Effects of Fish Peptides and Vitamin D
Acronym
BONITO
Official Title
Cardiometabolic Health Effects and Mechanisms of Action of Fish Nutrients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The overall goal of this study is to investigate the effects and the mechanisms of action of a fish peptide and vitamin D on glucose metabolism, insulin secretion, and cardiometabolic risk profile in overweight men. Transcriptomic and metabolomic approaches will be used to study the acute physiological effects of fish nutrients and to discover gene/metabolite networks that underlie these effects.
Detailed Description
Sedentary lifestyle and excess calorie intake have contributed to a dramatic increase in the occurrence of obesity, metabolic syndrome (MetS), type 2 diabetes (T2D) and cardiovascular disease (CVD) The first step in reducing the excessive CVD risk associated with the presence of the MetS is the adoption of a healthier lifestyle. A balanced diet, including high-nutritive and low-energy foods such as fish, is an important component of a healthy diet. Fish is a major source of n-3 PUFA, high-quality protein, and other essential nutrients such as vitamin D. Fish consumption may therefore improve the components of the MetS and reduce the incidence of T2D and CVD in obese subjects.The foundation of this project stems from the well-recognized fact that few Canadians meet the weekly dietary recommendation for fish consumption (i.e. 2 servings/week) and thus intakes of both n-3 polyunsaturated fatty acid (PUFA) and fish protein are low in the general population, and even lower in obese subjects. Since some people simply dislike fish and because certain types of fish contain toxic contaminants, including heavy metals and environmental pollutants, fish consumption remains low. Therefore, dietary choices limit intake of its key nutrients, thus increasing risk for MetS, T2D and CVD. Also, fish is one of the richest food sources of dietary vitamin D which may also contribute to the health benefits of fish consumption. Indeed, it is currently estimated that ∼40% of Canadians have low serum 25-hydroxyvitamin D [25(OH)D] concentrations (≤50 nM) and that ∼70% are below 75 nM. In addition, obesity is an important risk factor for low serum 25(OH)D.The main objective of this study is to investigate the acute effects and mechanisms of action of fish peptide and vitamin D on glucose metabolism, parameters of insulin sensibility and secretion, and cardiometabolic risk profile in overweight men. A four-arm randomized crossover design will be used to test the metabolic effects of consuming prior to a 3h-oral glucose tolerance test (OGTT), supplements containing either fish peptide (3 grams), vitamin D3 (1000 IU), a combination of fish peptide + vitamin D3 or a placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes, Insulin Resistance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fish peptide
Arm Type
Experimental
Arm Title
Vitamin D
Arm Type
Experimental
Arm Title
Fish peptide + Vitamin D
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish peptide supplement
Intervention Description
6 capsules of fish peptide supplement (3g/each) administered prior to one of the OGTT
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D supplement
Intervention Description
1 tablet of vitamin D3 (1000 UI) administered prior to one of the OGTT
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish peptide + Vitamin D3 supplements
Intervention Description
6 capsules of fish peptide (3g/each) + 1 tablet of vitamin D3 (1000 UI) administered prior to one of the OGTT
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
7 tablets of placebos administered prior to one the OGTT
Primary Outcome Measure Information:
Title
Serum glucose area under the curve (Glucose AUC)
Description
The area under the curve for serum glucose concentration is calculated from 0-180min after 75g glucose is ingested
Time Frame
0-180 min
Secondary Outcome Measure Information:
Title
Serum insulin area under the curve (Insulin AUC)
Description
Area under the curve for serum insulin
Time Frame
0-180 min
Title
Serum C-peptide area under the curve (C-peptide AUC)
Description
Area under the curve for serum C-peptide
Time Frame
0-180 min
Title
Serum triglycerides concentrations
Description
changes in the triglycerides concentration at each time point of the OGTT
Time Frame
-15, 0, 15, 30, 60, 120, 180 min post 75g glucose
Title
Serum 25(OH)D concentrations
Description
Changes in the 25(OH)D concentration measured before each OGTT
Time Frame
4 weeks
Title
Cardiometabolic risk profile in serum
Description
Changes in cardiometabolic profile measured in serum before each OGTT
Time Frame
4 weeks
Title
Gene expression profile
Description
peripheral blood mononuclear cells (PBMCs) gene expression
Time Frame
4 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: overweight (BMI 25-40 kg/m2) fasting triglycerides ≥ 1.5 mmol/L fasting insulin ≥ 60 pmol/L non-smoking stable weight in the past 3 months Exclusion Criteria: diabetes chronic diseases taking drugs that could affect glucose or lipid metabolism taking dietary supplements or natural health products major surgery 3 months prior to the study fish or seafood allergy lactose intolerance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Claude Vohl
Organizational Affiliation
Instute of Nutrition and Functional Foods, Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Nutrition and Functional Foods (INAF), Laval University
City
Quebec
ZIP/Postal Code
G1V 0A6
Country
Canada

12. IPD Sharing Statement

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Pilot Study on Metabolic Effects of Fish Peptides and Vitamin D

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